MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40Q

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported that patient presented to the er after receiving multiple inappropriate shocks for atrial fibrillation with rapid ventricular response.Device continued to shock even when a magnet was placed over the device but when the magnet was taped over the device no shocks were observed.The device was reprogrammed, and remains implanted.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: QUADRA ASSURA CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4359242
• MDR Text Key: 5235528
• Report Number: 2938836-2014-19123
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CD3365-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR